FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
36673–36696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2014
ALL-CERAMIC ZIRCONIA BLOCK
K141162 · EIH
Rizhao Huge Dental Industry Co., Ltd.
Dental · 114d
Cleared Aug 27, 2014
DOSELAB PRO
K141230 · IYE
Mobius Medical Systems, LP
Radiology · 106d
Cleared Aug 27, 2014
LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
K141239 · LYZ
Zibo Litong Plastic Products Co., Ltd.
General Hospital · 106d
Cleared Aug 27, 2014
RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K141305 · LYZ
Shijiazhuang Richful Plastic Co., Ltd.
General Hospital · 100d
Cleared Aug 27, 2014
AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K141307 · LYZ
Shijiazhuang Aok Plastic Co., Ltd.
General Hospital · 100d
Cleared Aug 27, 2014
CIANNA MEDICAL SGS SYSTEM
K141318 · PDW
Cianna Medical, Inc.
Radiology · 99d
Cleared Aug 27, 2014
OPAL CHIRO, 20/20 P-DR
K141435 · MQB
2020 Imaging
Radiology · 89d
Cleared Aug 27, 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · FMF
Biomet, Inc.
General Hospital · 57d
Cleared Aug 26, 2014
VERITRACT ENTERAL FEEDING TUBE SYSTEM
K133334 · KNT
Veritract, Inc.
Gastroenterology & Urology · 301d
Cleared Aug 26, 2014
SLIT LAMP SL-D701
K133667 · HJO
Topcon Corp.
Ophthalmic · 270d
Cleared Aug 26, 2014
CONFIRM BIOACTIVE
K133678 · MQV
Globus Medical, Inc.
Orthopedic · 270d
Cleared Aug 26, 2014
TENS
K133979 · NUH
Sunmas (H.K.) Trading Limited
Neurology · 243d
Cleared Aug 26, 2014
CAYA CONTOURED DIAPHRAGM
K140305 · HDW
Kessel Medintim GmbH
Obstetrics & Gynecology · 200d
Cleared Aug 26, 2014
DIOTECH LASER FIBER
K140458 · GEX
Diotech CO
General & Plastic Surgery · 183d
Cleared Aug 26, 2014
POWDER-FREE NITRILE EXAMINATION GLOVES, ORANGE, COLOR
K141021 · LZA
Hl Rubber Industries Sdn Bhd
General Hospital · 127d
Cleared Aug 26, 2014
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
K141095 · FYA
Stryker Corporation
General Hospital · 120d
Cleared Aug 26, 2014
VERTIFORM POSTERIOR FIXATION SYSTEM
K141291 · NKB
Next Orthosurgical
Orthopedic · 99d
Cleared Aug 26, 2014
VixWin Platinum
K141451 · LLZ
Imaging Sciences International (Dba...
Radiology · 85d
Cleared Aug 26, 2014
PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
K141497 · EHD
Osstem Implant Co., Ltd.
Radiology · 81d
Cleared Aug 26, 2014
BASAL DIGITAL THERMOMETER
K141505 · FLL
K-Jump Health Co., Ltd.
General Hospital · 81d
Cleared Aug 25, 2014
STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K133322 · FRC
Steritec Products Mfg Co, Inc.
General Hospital · 300d
Cleared Aug 25, 2014
3B RESMART BPAP 25A, BMC RESMART BPAP 25A
K133769 · BZD
3B Medical, Inc.
Anesthesiology · 257d
Cleared Aug 25, 2014
ORTHOHUB EXTERNAL FIXATOR SOFTWARE
K140550 · OSN
Orthohub, Inc.
Orthopedic · 174d
Cleared Aug 25, 2014
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
K141294 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 98d